NEW YORK and MELBOURNE, Australia, Nov. 24, 2014 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB) (USOTC:MBLTY) provided an update to the market on the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act) which takes effect today in Japan. This Act establishes a framework for expedited approval in Japan for regenerative medical products.

Mesoblast Chief Executive Silviu Itescu said that the Company intends to seek expedited conditional approvals in Japan for its cell therapy product candidates by capitalizing on its clinical data generated to date, its strong intellectual property, and its manufacturing know how.

Key takeaways of the PMD Act for Mesoblast are:

Conditional product approvals will be based on existing Phase 2 trial results demonstrating probable efficacy and safety with bridging studies in Japanese patients

Conditional approvals will allow sales of each product candidate for up to 7 years

Full approval is expected to require further confirmation of safety and efficacy in a larger population.

The PMD Act will enable Mesoblast to make its cell therapy product candidates available sooner to patients with unmet medical needs, and to achieve nearer term revenues in Japan ahead of other major jurisdictions.

In order to achieve its corporate objectives in Japan, Mesoblast

has completed prioritization of lead product candidates based on assessment of commercial opportunity and feasibility in Japan